Moe Alsumidaie’s Post

In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset. Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi

The pharmaceutical industry is undergoing a significant transformation as the demand for complex therapies continues to grow. These therapies require intricately designed clinical trials, with the integration of robust data analytics and regulatory expertise from the early stages of development becoming essential. Early involvement of medical affairs professionals ensures that clinical trials are not only compliant but also optimized for patient recruitment and reflective of real-world conditions. This shift is reshaping the drug development landscape. By prioritizing early-stage integration, the industry is driving greater efficiency in trial design, enhancing patient recruitment strategies, and ultimately improving patient outcomes. These advancements underscore the importance of adapting to new methodologies and leveraging specialized expertise to navigate the complexities of modern clinical trials.

It's fascinating to witness the pharmaceutical industry's shift towards more complex therapies and the crucial role that early integration of medical affairs plays in this transformation. By embedding robust data analytics and regulatory expertise right from the outset, we're not only enhancing compliance but also refining clinical trials for better patient recruitment and real-world applicability. This proactive approach is vital for streamlining drug development and optimizing outcomes, marking a significant evolution in bringing therapies to those needing them.

Decentralized clinical trials are taking the healthcare industry by storm, but pharmaceutical companies should bear in mind that this model may not always be the most effective.     How do you determine which strategies are optimal for ensuring research is both insightful and manageable for participants?    Talk to patients!      As Executive Director of Decentralized Clinical Trials at Worldwide Clinical Trials, Scott Palmese says, “Understand when patients will welcome decentralized tactics, and when they will not. If you don’t know the community, perhaps you should not be blanketing tactics that may not make sense and could drive patients away.”    Learn more about the role of decentralized trials below: https://lnkd.in/eZMHXbiK #patientvoices #patientcentric #clinicaltrials 

🔑 Tips to Strengthen Clinical Trials by Improving the Patient Experience by pharmaphorum. 💡 Clinical trials designed without patient input risk missing the mark. A patient-centric approach not only improves trust in the pharmaceutical industry but also boosts enrolment, engagement and retention—accelerating access to better medicines. Here’s how sponsors can economically integrate patient experiences into trial designs: - Simplify: Streamline processes and use plain, accessible language to connect with participants. - Offer Options: Design flexible protocols that accommodate diverse patient needs, like virtual visits or support for transportation. Tools to Use: Leverage resources like TransCelerate’s Clinical Trial Registration Tool for patient-friendly descriptions and the Study Participant Feedback Questionnaire (SPFQ) to gather real-time feedback during the trial. 🌟 Options that fit patients’ lives lead to better participation and stronger research outcomes. Read more about it: https://lnkd.in/dc8-rXpx #PatientCentricity #ClinicalTrials #HealthcareInnovation #PatientExperience

Digital Health Technologies (DHTs) are transforming clinical trials, making them more efficient and cost-effective. Michelle Crouthamel DBA, Digital Science Head at AbbVie, recently highlighted the benefits of DHTs at the 2024 SCOPE Summit, emphasizing the need for industry-wide agreements on key performance indicators. Case studies, including Aleve PM and Bellerophon Therapeutics trials, have demonstrated the cost reduction and efficiency benefits of DHTs. Additionally, DHTs offer precision in monitoring diseases with traditionally challenging diagnosis and monitoring tools. To overcome digital implementation challenges in clinical trials, AbbVie adopts an Agile, Bold, Collaborative, and Duty-Beyond ethos, which emphasizes collaboration over compliance. Regulatory engagement is also crucial, with a focus on continuous dialogue with regulatory bodies. Despite the transformative potential of DHTs, the absence of standardized metrics for DHT effectiveness is a significant hurdle. To address this, Michelle Crouthamel stressed the importance of industry-wide agreements on key performance indicators. For more details on AbbVie's leading efforts with DHTs in clinical trials, visit Clinical Trial Vanguard. #DigitalHealth #ClinicalTrials #Innovation #RegulatoryStrategy #HealthTech

Introducing our latest investment - Trially 🩺 Every year 80% of clinical trials do not reach recruitment targets in their allotted time and study delays cost anywhere between $600K-$8M per trial per day. Trially aims to tackle this issue head-on with its AI platform designed for clinical trial recruitment and site discovery. Trially helps site networks by automating the EHR patient search across all recruiting studies in seconds, effectively reducing patient search costs by up to 99% and increasing the number of qualified candidates available by 100x. The co-founders, Kyle McAllister, Trevor Welch, and Ramon Prieto, bring a wealth of industry knowledge and technical expertise to address this challenging problem. Discover why we believe Trially is poised to revolutionize the pharmaceutical clinical trial landscape 🚀 ⤵️

I have to be honest, this really got me, as at the latest SCOPE Summit, Rob Goodwin, Sr. VP at Pfizer, shared a poignant narrative that struck a chord with attendees. Reflecting on the significance of time in clinical trials, he drew inspiration from Beth Hebron's battle with ALS, where every minute of waiting for a treatment held immense value. This mantra, "Time is Life," resonated deeply, emphasizing the urgency and impact of timely clinical development which was extremely powerful, l I'm certain you all will agree! 👏🏼🙏 Expressing gratitude for collaborative efforts within the clinical trial ecosystem, Goodwin highlighted the pandemic as a lesson in accelerated development through unprecedented collaboration. However, he cautioned against reverting to old habits post-pandemic, urging sustained progress and accountability through public commitments. Pfizer's focus on diversity, improved interactions, and enhancing satisfaction underscores their commitment to patient-centric clinical trials and strategic consistency 💡 Embracing innovation without compromising quality, Goodwin called for an industry-wide integration of technological advancements in clinical trials. Balancing efficiency with safety and efficacy, he advocated for novel methodologies and decentralized approaches to deliver treatments swiftly without sacrificing quality. By adapting to new pathways and technologies, companies can serve patients effectively while thriving in a dynamic healthcare landscape 💻📈 PfizerLink, a pioneering patient recruitment initiative, aims to revolutionize participant engagement in clinical research. With over 35,000 sign-ups and the potential for further expansion, PfizerLink signifies a paradigm shift in patient recruitment, ensuring smarter matches and reduced screen-fail rates at sites. Looking ahead, Goodwin stressed the importance of continual innovation and patient impact as the driving forces shaping the future of clinical development 🚀 As the clinical trial landscape evolves, prioritizing patient benefits aligns with corporate growth and stakeholder interests. This commitment to advancement and patient-centricity underscores the transformative potential of embracing change in clinical development, where time truly is synonymous with life ✅💊 #Pfizer #RobGoodwin #ClinicalTrials #ClinicalResearch #BetterFuture #Innovation #PatientCentricity #Diversity #Biotechnology #Pharmaceuticals #LifeScience #ElixirAssociates #StaffingPartner

In clinical trials certain metrics, such pain symptoms, are better recorded as near to real-time as feasible, while others may be efficiently gathered during site visits. This is where patient-reported outcomes (PROs) come in. Read More: https://lnkd.in/dr9-SviG #ePRO #clinicalsupply #ClinicalTrials #Clinicalresearch #ClinicalStudy #PharmaceuticalIndustry #PharmaTech #Pharma #Pharmaceutical #Healthcare #HealthcareIndustry #HealthcareSector #HealthcareInnovation #Blog #Blogs #Octalsoft

Complete Guide of " Clinical Trials" Full Report is Ready | Download free sample PDF : https://lnkd.in/d-Cent4i   The global clinical trials market size was valued at USD 87.22 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 6.49% from 2024 to 2033. The market growth spiked in 2020 owing to the COVID-19 pandemic. This growth pattern was witnessed by both virtual clinical trials and traditional ones. Several companies invested heavily in novel drug development to minimize COVID-19 patient burden. One such example being, in 2020, Synairgen plc and Parexel collaborated on a Phase III study of Interferon-beta (IFN-beta) treatment for COVID-19. Furthermore, rapid technological evolution, rising prevalence of chronic diseases, globalization of clinical trials, penetration of personalized medicine and a rise in demand for CROs for conducting research activities is expected to positively impact the market growth.   Phase III segment led the market and accounted for 53.13% of the total revenue share in 2023.  clinical trial statistics indicate market growth due to rising phase III trials, involving a large number of subjects. The median cost for a single-phase III trial is over USD 19.0 million. Also, phase III requires a higher number of patients and often a longer treatment period. According to a clinical trial logistics survey by Nice Insights, 35.0% of phase III clinical trials are outsourced and the number is likely to increase owing to the growing number of investigational drugs advancing to the next phase.   North America accounted for 50.3% of the global market in 2023 and is expected to continue its dominance over the forecast period. This can be attributed to an increase in R&D investments and a rise in the adoption of new technologies in clinical trials in this region. For instance, the implementation of virtual services in various stages of clinical trials by market players, such as IQVIA and PRA Health Sciences, is anticipated to further propel the North American market growth.